PlainRecalls
FDA Devices Critical Class I Ongoing

Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WWNA. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.

Reported: June 18, 2025 Initiated: May 21, 2025 #Z-1915-2025

Product Description

Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WWNA. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.

Reason for Recall

Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.

Details

Recalling Firm
Covidien
Units Affected
4842
Distribution
Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Singapore, Lithuania, Kazakhstan, Slovenia, Colombia, China, Qatar, United Arab Emirates, Greece, Saudi Arabia, Nigeria, Romania, Netherlands, Lebanon, Oman, Jordan, Malawi, India, Croatia, Portugal, Turkey, Brazil, Pakistan, Trinidad and Tobago, Slovakia, Chile, Egypt, Switzerland, South Africa, Thailand, Bangladesh, Myanmar, Peru, Uruguay, Hungary, Argentina, Iran, Islamic Republic Of, Costa Rica, Vietnam, Australia, Guatemala, Mexico, Guyana, Jamaica, Dominican Republic, Bahamas, Bosnia and Herzegovina, South Korea, Tunisia, Ukraine, Uzbekistan, Indonesia, Burkina Faso, Italy, Panama, Sri Lanka, Malaysia, Namibia, Swaziland, Spain, Philippines, Bhutan, Mauritius, Poland, France, Cambodia, Czechia, Israel, Norway, Russian Federation, United Kingdom, Canary Islands, Kenya, Czech Republic, Croatia , Estonia, Maldova, Palestine.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled?
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WWNA. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.. Recalled by Covidien. Units affected: 4842.
Why was this product recalled?
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 18, 2025. Severity: Critical. Recall number: Z-1915-2025.